FIRST TREATMENT FOR PRIMARY PROGRESSIVE MS APPROVED IN AUSTRALIA

September 11, 2017

MS Research Australia has been reporting on every step that Ocrevus a new MS medication, has taken on its journey to become the first ever approved treatment for progressive MS and relapsing MS in Australia. In July, Ocrevus reached another milestone, it was listed on the PBS for relapsing MS. MS Research Australia is continuing to advocate for Ocrevus’s inclusion on the PBS for progressive MS, and is calling on the MS community to add its voice in the call for its inclusion.

Australia has moved swiftly and positively for people with MS in regards to Ocrevus (ocreluzimab) and is the second country in the world, after the U.S, to approve this very important therapy. Ocrevus has been recommended for listing on the Pharmaceutical Benefits Scheme (PBS) for relapsing MS. Now we await with great anticipation the outcome of the Pharmaceutical Benefits Advisory Committee meeting in November this year where Ocrevus will be considered for listing on the PBS for primary progressive MS.

Affordable access to all MS treatments is paramount, but most intensely so for those with progressive forms of MS who, have no treatment options available. Members of the MS community can have their voice heard by making a submission to the PBAC via the pbs.gov.au website before 4 October. Primary progressive MS is a form of MS in which there is a gradual worsening of symptoms and disability right from the start, without the periods of attack and recovery that characterise relapsing remitting MS. 10-15% of people diagnosed have primary progressive MS.

The reasons why some people develop primary progressive MS rather than relapsing remitting MS are still not clear. There is a huge research effort underway to shed light on why this is, with significantly more work needed. Up until now, all of the treatments that have worked for people with relapsing remitting MS have sadly failed when they have been tested in clinical trials for primary progressive MS, leaving researchers, clinicians and people with MS disappointed and frustrated.

Ocrevus has shown very good results in clinical trials for relapsing remitting MS, significantly suppressing relapses and delaying the development of disability. In the trials for primary progressive MS, the effect size was more modest, slowing down disability progression by around 25% in people who received Ocrevus compared to those who received the placebo. Ocrevus won’t completely stop progression in people with primary progressive MS, but it can be expected to preserve physical function and quality of life for longer. Most importantly, it also provides vital clues as to what is happening and where to go from here. This is just the beginning of a renewed and targeted push to develop highly effective treatments that will put a stop to disability progression altogether.

Ocrevus belongs to a class of drugs known as monoclonal antibodies. It recognises and binds to just one molecule in the body. This molecule is called CD20 and is only found on the surface of a specific type of immune cell known as B cells. It binds to CD20 on the B cell, triggering the destruction of this cell. This then depletes the number of these immune cells in a person’s body. Traditionally, B cells have not been the primary focus of research in MS.

The success of Ocrevus, and other treatments that target B cells has however refocussed researchers’ attention. The Ocrevus trials have not only been a success in terms of treatment, they are also a success in helping us understanding the biology of MS. This has given new impetus to the researchers working on progressive MS and to the pharmaceutical industry – opening up the field and providing new incentives to re-double efforts.

The International Progressive MS Alliance, of which MS Research Australia is a managing member, is playing a central role in this effort. The Alliance has brought together, not only MS organisations and researchers, but also industry representation and regulators. This is to ensure that all of the right expertise is in the room to speed up progressive MS treatments and information, from the laboratory, pre-clinical testing, clinical trials and, finally, through the regulatory approvals process.